Structure for applying sprayable wound treatment material

ABSTRACT

The present disclosure relates to surgical instruments, structures and methods for enhancing the properties of tissue to be repaired or joined. According to an aspect of the present disclosure, a surgical stapling apparatus is provided including a wound treatment material dispersion system for delivering wound treatment material to a target surgical site. The dispersion system includes an aperture formed in the anvil assembly oriented to dispense wound treatment material in an outward direction; and a source of wound treatment material in fluid communication with the aperture of the anvil assembly.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a Continuation Application claiming thebenefit of and priority to U.S. application Ser. No. 11/250,277, filedon Oct. 14, 2005, which in turn claims the benefit of and priority toeach of U.S. Provisional Application Ser. No. 60/620,102, filed Oct. 18,2004, and U.S. Provisional Application Ser. No. 60/620,150, filed onOct. 18, 2004, the entire contents of each of which being incorporatedherein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical instruments and methods forenhancing properties of tissue repaired or joined by surgical staplesand, more particularly to surgical stapling apparatus and structureconfigured to apply biocompatible wound treatment material.

2. Discussion of Related Art

Throughout the years the medical field has utilized various techniquesin an effort to join or bond body tissue together. Historically,suturing was the accepted technique for rejoining severed tissues andclosing wounds. Suturing was historically achieved with a surgicalneedle and a suturing thread, and more recently, with a variety ofpolymeric or metallic staples, as will be discussed below. The intendedfunction of sutures is to hold the edges of a wound or tissue againstone another during the healing process so as to reduce discomfort, pain,scarring and the time required for healing.

Recently, many procedures which in the past required conventionalsuturing have been replaced by staple suturing which involves theapplication of the staples to the edges of the wound or tissue with theuse of a surgical stapler. Surgical staplers have been developed forjoining adjacent tissue, for providing hemostasis of adjacent tissue andfor providing hemostasis in conjunction with cutting of adjacent tissue.Such surgical staplers include both linear and annular typeconfigurations. A typical linear stapler and cutter includes parallelrows of staples with a slot for a cutting means to travel between therows of staples.

Typical linear type staplers are disclosed in commonly assigned U.S.Pat. No. 6,045,560 to McKean et al., U.S. Pat. No. 6,032,849 to Mastriet al., and U.S. Pat. No. 5,964,394 to Robertson, the entire contents ofeach of which are incorporated herein by reference. A typical annularstapler and cutter, including a plurality of annular rows of staples,typically two, and an annular blade disposed internal of the rows ofstaples, is disclosed in commonly assigned U.S. Pat. No. 5,799,857 toRobertson et al. and U.S. Pat. No. 5,915,616 to Viola et al., the entirecontents of each of which are incorporated herein by reference.

These types of surgical staplers secure adjoining body tissue forimproved cutting, join layers of tissue to one another and providehemostasis by applying parallel or annular rows of staples tosurrounding tissue as the cutting means cuts between the parallel orannular rows. Accordingly, by enabling a surgeon to perform all of thesetasks simultaneously, surgical staplers have been effective indecreasing the amount of time it takes to fasten tissue together. Toeven further enhance joining and hemostasis in instances where thestapler is used in highly vascularized tissue, surgical staplers withmultiple rows of staples have been used with a high degree of success.

Other surgical procedures utilize pledgets, buttresses or other types ofreinforcement materials and fabrics. These buttresses are typicallyplaced over the tissue contacting surface of the anvil and/or the tissuecontacting surface of the cartridge of the surgical stapling instrumentand secured against the target tissue during the firing of the surgicalstapling instrument. Reference may be made to U.S. Pat. No. 5,542,594,the entire content of which is incorporated herein by reference, for amore detailed discussion of the use of buttresses in cooperation withsurgical stapling instrument.

Still other surgical procedures involve the step of applying (e.g., byspraying, brushing, etc.) an adhesive material and/or a sealant materialto the external surface of the target surgical site following thesurgical stapling procedure.

Another procedure which has been developed includes the use ofbiological tissue adhesives have recently been developed for tissuerepair and the creation of anastomoses. Generally, biological adhesivesbond separated tissues together to aid in the healing process and toenhance the tissue strength. Such adhesives may be used instead ofsuturing and stapling for example in surgical procedures for the repairof tissue or the creation of anastomoses.

The application of a suitable biocompatible adhesive offers manyadvantages to the patient and the surgeon alike such as, for example,the avoidance of penetration of tissue by needles and/or staples, aswell as the immediate sealing of the tissue being treated. Moreover, useof a biocompatible adhesive tends to minimize foreign body reaction andscarring. Despite these advantages, however, the weakness along thetissue seam remains as a primary disadvantage in the use ofbiocompatible adhesives.

Therefore, there is a need for surgical stapler instruments, for examplesurgical fasteners or staplers which reduce the trauma suffered by apatient, reduce the number of gaps between or at individual staplesites, reduce leakage of fluids, reduce bleeding, and/or which create arelatively strong bond between adjacent body tissues, e.g., along staplelines and tissue seams.

SUMMARY

The present disclosure relates to surgical instruments, structures andmethods for enhancing the properties of tissue to be repaired or joined.

According to an aspect of the present disclosure, a surgical staplingapparatus is provided including a body portion; an actuation assemblyoperatively supported at a proximal end of the body portion; a staplepusher member operatively disposed at a distal end of the body portionand being operatively connected to the actuation assembly for expellingan annular array of staples from the body portion; an anvil assemblymovably mounted at the distal end of the body portion for movementtoward and away from the staple pusher member; an approximation assemblyextending between the body portion and the anvil assembly for moving theanvil toward and away from the tubular body portion; and a woundtreatment material dispersion system for delivering wound treatmentmaterial to a target surgical site. The dispersion system includes anaperture formed in the anvil assembly oriented to dispense woundtreatment material in an outward direction; and a source of woundtreatment material in fluid communication with the aperture of the anvilassembly.

In an embodiment, the dispersion system may include a nozzle supportedon an anvil member of the anvil assembly, and wherein the apertureformed in the anvil assembly is provided in the nozzle. The dispersionsystem includes a lumen extending through a stem of the anvil assemblywhich is in fluid communication with the aperture formed in the nozzle.The lumen of the stem of the anvil assembly may be capable of fluidcommunication with the source of wound treatment material.

The surgical stapling apparatus may be configured and adapted todispense wound treatment material onto the target surgical site at leastone of before, during and after firing of the surgical staplingapparatus.

According to another embodiment of the disclosure, the source of woundtreatment material of the dispersion system is an ampoule which may beselectively positionable within a stem of the anvil assembly. Theampoule may be constructed from a breakable material. Accordingly,during use, upon compression of the ampoule, wound treatment materialmay be released from the ampoule for transmission to the aperture of theanvil assembly.

The dispersion system includes a piston configured and dimensioned forinsertion into the stem of the anvil assembly to rupture the ampoule andforce wound treatment material out through the aperture of the anvilassembly and onto the target surgical site at least one of before,during and after firing of the surgical stapling apparatus.

The ampoule defines a lumen therethrough and may include a plungerslidably positioned within the lumen thereof. The lumen of the ampoulemay be in fluid communication with the aperture of the anvil assemblywhen the ampoule is positioned within the stem of the anvil assembly.The dispersion system may include a piston configured and dimensionedfor insertion into the lumen of the ampoule to engage the plunger and toforce the plunger through the lumen of the ampoule to dispense woundtreatment material out through the aperture of the anvil assembly andonto the target surgical site at least one of before, during and afterfiring of the surgical stapling apparatus.

In an embodiment, the dispersion system may include at least one drapesupported on and substantially surrounding a stem of the anvil assembly.The drape includes an undeployed condition in which the drape is inrelatively close proximity to the stem of the anvil assembly, and adeployed condition in which the drape is in relatively spaced relationto the stem of the anvil assembly. Desirably, the dispersion systemincludes a first drape positioned distally of the aperture of the anvilassembly and a second drape positioned proximally of the aperture of theanvil assembly. Accordingly, in use, when the drapes are in thedeployable condition, the drapes direct the dispersion of the woundtreatment material.

It is envisioned that a stem of the anvil assembly may include anannular groove formed proximally and distally of the aperture of theanvil assembly. The surgical stapling apparatus may further include anannular blade retractably disposed at a distal end of the body portion,wherein the annular blade includes a plurality of openings formedtherein.

In an embodiment, the dispersion system may include a plurality oftubular members supported within a lumen of a stem of the anvilassembly. The tubular members define the source of wound treatmentmaterial. The tubular members have an undeployed condition in which thetubular members are disposed within the lumen of the stem, and adeployed condition in which the tubular members project from windowsformed in the stem of the anvil assembly. Accordingly, in use, when thetubular members are actuated from the undeployed to the deployedcondition, the tubular members rupture to dispense wound treatmentmaterial.

According to another aspect of the present disclosure, a surgicalstapling apparatus is provided and includes a body portion; an actuationassembly operatively supported at a proximal end of the body portion; astaple pusher member operatively disposed at a distal end of the bodyportion and being operatively connected to the actuation assembly forexpelling an annular array of staples from the body portion; an anvilassembly movably mounted at the distal end of the body portion formovement toward and away from the staple pusher member; an approximationassembly extending between the body portion and the anvil assembly formoving the anvil toward and away from the tubular body portion; and awound treatment material dispersion system for delivering woundtreatment material to a target surgical site. The dispersion systemincludes a plurality of needles retractably supported in needlereceiving slots provided in the staple pusher member, wherein when thesurgical stapling apparatus is fired the needles penetrate the targettissue and dispense wound treatment material; and a source of woundtreatment material associated with each needle receiving slot.

In an embodiment, the source of wound treatment material may include acapsule disposed within each needle receiving slot. The dispersionsystem may include a finger disposed in each needle receiving slot,wherein upon firing of the surgical stapling apparatus the fingers areadvanced through the needle receiving slots to rupture the capsules, todeploy the needles, and to push the wound treatment material through theneedles.

According to a further aspect of the present disclosure, a splash guardfor use in combination with an anastomotic surgical stapling apparatusis provided. The surgical stapling apparatus is desirably configured andadapted to deliver wound treatment material to a target surgical site.Accordingly, the splash guard includes a central hub defining a lumentherethrough for receiving a stem of an anvil assembly of the surgicalstapling apparatus; and an annular cuff supported on the central hub andextending at least substantially therearound, wherein the annular cuffis disposed radially outward of a staple line of the surgical staplingapparatus.

The splash guard may further include at least one spoke interconnectingthe annular cuff to the central hub. It is envisioned that at least theannular cuff and the at least one spoke are fabricated from abio-absorbable material. The annular cuff may be concave and may definean upper rim and a lower rim, wherein the upper and lower rims aredimensioned to contact an outer surface of the target surgical site.

According to yet another embodiment of the present disclosure, a woundtreatment material dispersion system for use in combination with ananastomotic surgical stapling apparatus is provided. The surgicalstapling apparatus may include an anvil assembly supported opposite astaple pusher member. The wound treatment material dispersion systemincludes a disc defining an outer edge and an inner edge, the discincluding a plurality of apertures formed therethrough; at least one ofan annular inner wall integrally connected to the inner edge of the discand an annular outer wall integrally connected to the outer edge; andwound treatment material disposed on a surface of the disc.

The inner annular wall of the wound treatment material dispersion systemis configured and dimensioned for positioning inwardly of the staplepusher member, and wherein the outer annular wall of the wound treatmentmaterial dispersion system is configured and dimensioned for positioningoutwardly of the staple pusher member. Desirably, the inner annular walland the outer annular wall are disposed along one side of the disc.

According to a further aspect of the present disclosure, a method ofperforming a surgical anastomosis procedure is provided. The methodincludes the step of providing a surgical stapling apparatus having ananvil assembly movably mounted with respect to a body portion and awound treatment material dispersion system for dispensing woundtreatment material onto a target surgical site. The wound treatmentmaterial dispersion system includes an aperture formed in the anvilassembly oriented to dispense wound treatment material in an outwarddirection; and a source of wound treatment material in fluidcommunication with the aperture of the anvil assembly. The methodfurther includes the steps of disposing an anvil assembly into a firstintestinal section and surgically securing the first intestinal sectionto the anvil assembly; disposing a distal end portion of the surgicalstapling apparatus into a second intestinal section and surgicallysecuring the second intestinal section to the distal end of the surgicalstapling apparatus; connecting the anvil assembly to the distal endportion of the surgical stapling apparatus; actuating the woundtreatment material dispersion system to dispense wound treatmentmaterial along an inner surface and between the first and the secondintestinal sections; and approximating the anvil assembly toward thetubular body portion.

The wound treatment material may be dispensed from at least one of ananvil member and an anvil stem of the anvil assembly. The woundtreatment material may be contained within an ampoule in the stem of theanvil assembly. Accordingly, the method may further include the step offiring the surgical stapling apparatus in order to release the woundtreatment material from the ampoule and to dispense the wound treatmentmaterial from the aperture of the anvil assembly.

The dispersion system may include a piston configured and adapted forengagement with the ampoule disposed within the stem of the anvilassembly. Accordingly, the method may further include the step ofadvancing the piston to release the wound treatment material from theampoule and to dispense the wound treatment material from the apertureof the anvil assembly.

In an embodiment, the dispersion system may include at least one drapesupported on and substantially surrounding a stem of the anvil assembly.The drape includes an undeployed condition in which the drape is inrelatively close proximity to the stem of the anvil assembly, and adeployed condition in which the drape is in relatively spaced relationto the stem of the anvil assembly. Accordingly, the method may includethe step of deploying the drape prior to dispersing wound treatmentmaterial. As such, when the drapes are in the deployable condition, thedrapes direct the dispersion of the wound treatment material.

The method may further include the step of placing a splash guard overthe stem of the anvil assembly prior to the connecting of the anvilassembly to the distal end portion of the surgical stapling apparatus.

The splash guard may include a central hub defining a lumen therethroughfor receiving a stem of an anvil assembly of the surgical staplingapparatus; and an annular cuff supported on the central hub andextending at least substantially therearound, wherein the annular cuffis disposed radially outward of a staple line of the surgical staplingapparatus. The splash guard may further include at least one spokeinterconnecting the annular cuff to the central hub. It is envisionedthat at least the annular cuff and the at least one spoke are fabricatedfrom a bio-absorbable material. The annular cuff may be concave and maydefine an upper rim and a lower rim, and wherein when the splash guardis disposed on the stem of the anvil assembly and the anvil assembly isapproximated toward the distal end portion of the surgical staplingapparatus, the upper and lower rims of the annular cuff are dimensionedto contact an outer surface of the first and second intestinal sections.

According to still another aspect of the present disclosure, a method ofperforming a surgical anastomosis procedure is provided. The methodincludes the steps of providing a surgical stapling apparatus having ananvil assembly movably mounted with respect to a body portion and awound treatment material dispersion system for dispensing woundtreatment material onto a target surgical site. The wound treatmentmaterial dispersion system includes a plurality of needles retractablysupported in needle receiving slots provided in the staple pushermember, wherein when the surgical stapling apparatus is fired theneedles penetrate the target tissue and dispense wound treatmentmaterial; and a source of wound treatment material associated with eachneedle receiving slot. The method further includes the steps ofdisposing an anvil assembly into a first intestinal section andsurgically securing the first intestinal section to the anvil assembly;disposing a distal end portion of the surgical stapling apparatus into asecond intestinal section and surgically securing the second intestinalsection to the distal end of the surgical stapling apparatus; connectingthe anvil assembly to the distal end portion of the surgical staplingapparatus; approximating the anvil assembly toward the tubular bodyportion; and actuating the wound treatment material dispersion system toinject the plurality of needles into at least one of the first andsecond intestinal sections and to dispense wound treatment materialthrough the needles.

The source of wound treatment material may include a capsule disposedwithin each needle receiving slot at a location proximal of the needle.The dispersion system may include a finger disposed in each needlereceiving slot. Accordingly, the method may include the step of firingthe surgical stapling apparatus to advance the fingers through theneedle receiving slots to rupture the capsules, to deploy the needles,and to push the wound treatment material through the needles.

In any of the embodiments disclosed above, the wound treatment materialis at least one of an adhesive, a sealant, a hemostat, and a medicament.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the present disclosure will become morereadily apparent and may be understood by referring to the followingdetailed description of an illustrated embodiment of a surgicalinstrument, apparatus or structure, taken in conjunction with theaccompanying drawings, in which:

FIG. 1 illustrates a perspective view of a surgical stapling apparatusaccording to an embodiment of the present disclosure;

FIG. 2 is a longitudinal cross-sectional view of the distal end of asurgical stapling apparatus including a wound treatment materialdispersion system in accordance with an embodiment of the presentdisclosure, wherein the surgical stapling apparatus is positioned withinthe operative site such that the anvil member is positioned distally ofthe anastomosis site and the surgical stapling apparatus is dispensingwound treatment material;

FIG. 3 is a longitudinal cross-sectional view of the surgical staplingapparatus of FIG. 2, wherein the anvil member is positioned proximallyof the anastomosis site and the surgical stapling apparatus isdispensing wound treatment material;

FIG. 4 is a perspective view of an anvil member according to anotherembodiment of the present disclosure;

FIG. 5 is perspective view of the anvil member of FIG. 4, with partsseparated;

FIG. 6 is a perspective view of the anvil member of FIG. 4 with the tipremoved therefrom;

FIG. 7 is a longitudinal cross-sectional view of the surgical staplingapparatus of FIG. 2, with the anvil member of FIGS. 4-6 operativelyconnected thereto, illustrating the surgical stapling apparatus havingthe tissue to be anastomosed clamped between the anvil member and thestaple pusher member prior to the firing thereof;

FIG. 8 is a longitudinal cross-sectional view of the surgical staplingapparatus of FIG. 2, with the anvil member of FIGS. 4-6 operativelyconnected thereto, illustrating the surgical stapling apparatus havingthe tissue to be anastomosed clamped between the anvil member and thestaple pusher member during or after firing of the surgical staplingapparatus;

FIG. 9 is a perspective view, with parts separated, of an anvil memberaccording to an alternate embodiment of the present disclosure;

FIG. 10 is a schematic longitudinal cross-sectional view of the anvilmember of FIG. 9;

FIG. 11 is a cross-sectional view of the anvil member of FIGS. 9 and 10,as taken through 11-11 of FIG. 10;

FIG. 12 is a schematic longitudinal cross-sectional view of the anvilmember of FIGS. 9-11, illustrating the dispersion of wound treatmentmaterial therefrom;

FIG. 13 is a perspective view of an alternate embodiment of the anvilmember of FIGS. 4-6, shown in an un-deployed condition;

FIG. 14 is a side elevational view of the anvil member of FIG. 12, shownin a deployed condition;

FIG. 15 is a schematic longitudinal cross-sectional view of the anvilmember of FIGS. 12 and 13 operatively connected to the distal end of thesurgical stapling apparatus and illustrating the target tissue clampedbetween the anvil member and the staple pusher member;

FIG. 16 is a side elevational view of yet another embodiment of theanvil member of FIGS. 4-6;

FIG. 17 is a schematic longitudinal cross-sectional view of the surgicalstapling apparatus including an annular knife according to the presentdisclosure, showing the surgical stapling apparatus in a post firedcondition;

FIG. 18 is a perspective view of an anvil member according to analternate embodiment of the present disclosure while in a firstcondition;

FIG. 19 is a perspective view of the anvil member of FIG. 18 while in asecond condition;

FIG. 20 is a longitudinal cross-sectional view of the distal end of asurgical stapling apparatus having a wound treatment material dispersionsystem, including the anvil member of FIGS. 18 and 19, operativelyassociated therewith, wherein the surgical stapling apparatus is in afirst position within an operative site;

FIG. 21 is a longitudinal cross-sectional view of the distal end of thesurgical stapling apparatus of FIG. 21, wherein the surgical staplingapparatus is in a second position in the operative site;

FIG. 22 is an enlarged longitudinal cross-sectional view of a surgicalstapling apparatus according to an alternate embodiment of the presentdisclosure;

FIG. 23 is an enlarged partial sectional view taken along lines 23-23 ofFIG. 22;

FIG. 24 is an enlarged view of the area indicated as 24 in FIG. 22;

FIG. 25 is a perspective view of a splash guard for use with thesurgical stapling apparatus disclosed herein;

FIG. 26 is a perspective longitudinal cross-sectional view of the splashguard of FIG. 25;

FIG. 27 is a perspective longitudinal cross-sectional view of the splashguard of FIG. 25 illustrating the splash guard following firing of thesurgical stapling apparatus;

FIG. 28 is a schematic, longitudinal cross-sectional view of the splashguard of FIGS. 25-27, in position at a target surgical site, thesurgical stapling apparatus being shown in phantom;

FIG. 29 is a top plan view of a wound treatment material dispersionsystem according to a further embodiment of the present disclosure;

FIG. 30 is a cross-sectional view of the wound treatment materialdispersion system of FIG. 29 as taken through 30-30 of FIG. 29;

FIG. 31 is a cross-sectional view of a wound treatment materialdispersion system according to another embodiment of the presentdisclosure as would be taken through 30-30 of FIG. 29;

FIG. 32 is a longitudinal cross-sectional view of a surgical staplingapparatus illustrating a method of using the wound treatment materialdispersion system of FIGS. 29 and 30 in conjunction therewith;

FIG. 33 is a longitudinal cross-sectional view of a surgical staplingapparatus illustrating an alternate method of using the wound treatmentmaterial dispersion system of FIGS. 29 and 30 in conjunction therewith;

FIG. 34 is a longitudinal cross-sectional view of the distal end of asurgical stapling apparatus illustrating a step in a method ofdispensing a wound treatment material to an anastomosis site; and

FIG. 35 is a longitudinal cross-sectional view of the distal end of thesurgical stapling apparatus of FIG. 34 illustrating a further step inthe method of dispensing a wound treatment material to an anastomosissite.

DETAILED DESCRIPTION OF THE EMBODIMENT

Embodiments of the presently disclosed surgical stapling apparatus willnow be described in detail with reference to the drawing figures whereinlike reference numerals identify similar or identical elements. As usedherein and as is traditional, the term “distal” refers to that portionwhich is furthest from the user while the term “proximal” refers to thatportion which is closer to the user.

Referring now in specific detail to the drawings, in which likereference numerals identify similar or identical elements throughout theseveral views, FIG. 1 shows a surgical stapling apparatus 10 whichemploys the structure for applying a dispersible wound treatmentmaterial in accordance with the present disclosure. Apparatus 10includes a handle assembly 12 having at least one pivotable actuatinghandle member 14, and further includes advancing means 16. Advancingmeans 16 includes a rotatable grip member 18 whose function will bedescribed below.

Extending from handle assembly 12, there is provided a tubular bodyportion 20 which may be constructed so as to have a curved shape alongat least a portion of its length. Tubular body portion 20 may also bestraight, or in other embodiments, tubular body portion 20 may beflexible to bend to any configuration. Body portion 20 terminates in astaple pusher member 22. Staple pusher member 22 includes an annulararray of staples 24. Positioned opposite staple pusher member 22 isprovided an anvil member 26 which is connected to apparatus 10 by stem28 at connection means 30. Anvil member 26 and staple pusher member 22are disclosed in commonly assigned U.S. Pat. No. 5,119,983, issued Jun.9, 1992, which is incorporated herein by reference.

While apparatus 10 is shown and described as utilizing a staple pushermember having an annular array of staples positioned on the tubular bodyportion, and having the anvil member positioned opposite the staplepusher member for movement towards and away from the staple pushermember, it is of course contemplated that the anvil member may bepositioned on the tubular body portion and the staple pusher member andarray of staples be positioned opposite the anvil member for movementtowards and away from the anvil member. Such a construction is to beconsidered within the scope of the present disclosure.

In operation, apparatus 10 is positioned within a tubular organ in thebody of the patient and the ends of the organ to be joined arepositioned in the gap between staple pusher member 22 and anvil member26 so that anvil member 26 is fully extended. As is conventional, theends of the organ may be secured over anvil member 26 and staple pushermember 22 by a purse string suture prior to approximation of anvilmember 26 in relation to staple pusher member 22. With anvil member 26and staple pusher member 22 purse string sutured, stem 28 of anvilmember 26 is coupled to connection means 30 disposed within staplepusher member 22.

In order to approximate anvil member 26 towards staple pusher member 22,grip member 18 is rotated to displace an inner rod member (not shown) ina proximal direction. This draws anvil member 26 into position adjacentstaple pusher member 22 and locates the ends of the tissue between thesetwo members.

Once the proper distance is set between anvil member 26 and staplepusher member 22 interlock means 32 may be released and actuatinghandles 14 may be pivoted to drive the staples through the tissue andagainst anvil member 26 to complete the circular anastomosis of thetubular organ. Reference may be made to U.S. Pat. No. 5,119,983,previously incorporated herein by reference for a more detaileddescription and discussion of the structure and operation of surgicalstapling apparatus 10.

Turning now to FIGS. 2 and 3, surgical stapling apparatus 10 mayinclude, according to an embodiment of the present disclosure, a woundtreatment material dispersion system configured to disperse (e.g.,spray, eject, squeeze, dispense, etc.) wound treatment material “W” ontothe inner surface of the anastomosed tissue “T”. The dispersion systemincludes a dispersion head or nozzle 29 provided at the distal end ofanvil member 26, and a lumen 31 extending through stem 28 of anvilmember 26 and terminating in at least one radially oriented channel 29 aformed in dispersion head 29. Lumen 31 is fluidly connected to a sourceof fluid, i.e., wound treatment material “W”, saline, etc. (not shown).When anvil member 26 is connected to the distal end of surgical staplingapparatus 10, lumen 31 of stem 28 is fluidly connected to/with a lumen30 a provided in connection means 30. It is envisioned that lumen 30 aof connection means 30 interconnects lumen 31 of anvil member 26 to thesource of fluid.

In use, as seen in FIGS. 2 and 3, following firing of surgical staplingapparatus 10, anvil member 26 is spaced from staple pusher member 22 inorder to release the tissue “T” clamped therebetween. With anvil member26, and particularly dispersion head 29, disposed distally of theanastomosis site “A”, wound treatment material “W” is forced throughlumen 30 a of connection means 30, through lumen 31 of anvil member 26and radially outward from channels 29 a of dispersion head 29.

As wound treatment material “W” is being dispersed from channels 29 a ofdispersion head 29, surgical stapling apparatus 10 is withdrawn in aproximal direction, as indicated by arrow “B” (see FIG. 3), untildispersion head 29 is disposed at a location proximal of the anastomosissite “A”. In so doing, wound treatment material “W” is applied to theinner surface of the tissue “T” from a location distal of theanastomosis site “A” to a location proximal of the anastomosis site “A”thereby coating the inner surface of the body lumen in and around theanastomosis site “A”.

It is envisioned that application of wound treatment material “W” to theanastomosis site “A” may help to reduce the incidence of anastomoticleakage by sealing the inner lumen of the anastomosis. It is furtherenvisioned that application of wound treatment material “W” to theanastomosis site “A” may help to adhere the anastomosed ends of thetissue “T” to one another.

It is contemplated that the rate of dispersion of wound treatmentmaterial “W” from dispersion head 29 is selected such that sufficientwound treatment material “W” is applied to the inner surface of the bodylumen in order to effectuate sufficient tissue sealing and adhesion andto not interfere with the flow of materials through the body lumen.

It is envisioned that wound treatment material “W” may be asubstantially non-viscous fluid or liquid such that the wound treatmentmaterial “W” may freely flow from dispersion head 29. It is furtherenvisioned that the wound treatment material “W” dispended from surgicalstapling apparatus 10 may be in the form of a foam which expands tomomentarily radially fill the cavity of the body lumen in and around theanastomosis site “A”, to thereby completely coat the inner surfacethereof with wound treatment material “W”, and which collapses after aperiod of time to re-open the passageway of the body lumen.

Turning now to FIGS. 4-8, a wound treatment material dispersion system,according to an alternate embodiment of the present disclosure, is shownand described. The dispersion system of FIGS. 4-8 includes an anvilmember 126 which is connectable to connection means 30 of surgicalstapling apparatus 10.

As seen in FIGS. 4-6, anvil member 126 includes a hollow tubular stem128 having an open proximal end 128 a and at least one port 128 b formedin a side surface thereof, an anvil head 130 operatively connected to adistal end of stem 128, an ampoule 132 selectively positionable withinstem 128, and a tip or cap 134 selectively operatively connectable toproximal end 128 a of stem 128 for maintaining ampoule 132 within stem128.

Ampoule 132 is made from a frangible or breakable material, such as, forexample, glass, metal, polymers and the like, and is configured toretain a quantity of a wound treatment material “W” therein. As will bedescribed in greater detail below, the wound treatment material “W”,retained in ampoule 132, is dispensed therefrom upon rupturing orbreaking of ampoule 132. In particular, as will be discussed in greaterdetail below, with ampoule 132 positioned within stem 128, ampoule 132may be ruptured by longitudinally compressing ampoule 132. In so doing,the wound treatment material “W”, retained in ampoule 132, is dispersedinto stem 128 wherein the force of compression further urges the woundtreatment material “W” out through the at least one port 128 b.

Turning now to FIGS. 7 and 8, use of the wound treatment materialdispersion system of FIGS. 4-6, in connection with surgical staplingapparatus 10, is shown and described. In particular, with ampoule 132disposed within stem 128 and cap 134 (see FIGS. 4 and 5) secured toproximal end 128 a of stem 128, anvil member 126 is introduced into oneside of the anastomosis. The tissue “T” is purse string sutured to stem128 such that the purse string suture is located distally of the atleast one port 128 b.

As seen in FIG. 7, with anvil member 126 introduced into one side of theanastomosis, cap 134 is removed and stem 128 of anvil member 126 isoperatively connected to connection means 30. Connection means 30includes a piston or plunger 33 having a distal end configured toslidably enter proximal end 128 a of stem 128 and engage ampoule 132.With anvil member 126 connected to the distal end of surgical staplingapparatus 10, the surgical procedure is continued as described above.

In the present procedure, when actuating handles 14 are squeezed to firesurgical stapling apparatus 10, as seen in FIG. 8, piston 33 is advancedin the direction of arrow “C”, thereby compressing ampoule 132 withinstem 128 and causing ampoule 132 to rupture and release the woundtreatment material “W” retained therein. With ampoule 132 ruptured,continued squeezing of handles 14 continues to advance piston 33 throughstem 128 and squeeze the wound treatment material “W” out of stem 128through ports 128 b. The wound treatment material is thus dispersed ontothe anastomosis site “A”.

Desirably, the stroke and/or distal advancement of piston 33 ismechanically timed such that piston 33 ruptures ampoule 132 and causesthe wound treatment material “W” to disperse either prior to orsimultaneously with the firing of the surgical staples.

Turning now to FIGS. 9-11, a wound treatment material dispersion system,according to yet another embodiment of the present disclosure, is shownand described. The dispersion system of FIGS. 9-11 is substantiallysimilar to the dispersion system of FIGS. 4-8 and thus will only bediscussed in detail to the extent necessary to identify differences inconstruction and operation.

As seen in FIGS. 9-12, ampoule 132 includes a body portion 134 having anub 135 extending axially therefrom, and defining a lumen 134 a througheach of body portion 134 and nub 135. Nub 135 has a smallercross-sectional dimension than body portion 134 and defines a shoulder135 a. Ampoule 132 further includes a plunger 136 slidably disposedwithin lumen 134 a. Plunger 136 forms a fluid tight seal with the innersurface of body portion 134. Desirably, wound treatment material “W” isretained within lumen 134 a of ampoule 132.

Stem 128 of anvil member 126 defines a cavity 129 for selectivelyreceiving ampoule 132 therein. As seen in FIGS. 11-12, a distal end ofcavity 129 defines a distal pocket 129 a configured to receive nub 135of ampoule 132 therein. Pocket 129 a is dimensioned such that shoulder135 a of ampoule 132 contacts or engages a corresponding shoulder 129 bformed in cavity 129.

Desirably, as seen in FIGS. 11-12, ports 128 b of stem 128 are in fluidcommunication with pocket 129 a of cavity 129. Preferably, ports 128 bare formed at a location distal of a distal-most surface of nub 135. Inthis manner, when ampoule 132 is placed within cavity 129 of stem 128,lumen 134 a of ampoule 132 is in fluid communication with ports 128 b.As seen in FIG. 11, ports 128 b define a manifold to divide thedispersion of wound treatment material to different radial segmentsaround stem 128.

As seen in FIG. 12, in operation, upon distal advancement of plunger 136through lumen 134 a of ampoule 132, wound treatment material “W” isforced through nub 135, into distal pocket 129 a, and out through ports128 b. It is envisioned that a piston 33, or some other device or method(e.g., pneumatic) may be used to advance plunger 136 distally throughlumen 134 a.

Turning now to FIGS. 13-15, a wound treatment material dispersionsystem, according to yet another embodiment of the present disclosure,is shown and described. The dispersion system of FIGS. 13-15 issubstantially similar to the dispersion system of FIGS. 4-8 and thuswill only be discussed in detail to the extent necessary to identifydifferences in construction and operation.

As seen in FIGS. 13-15, anvil member 126 includes a first expandabledrape 140 a operatively connected to and at least substantiallysurrounding stem 128 at a location distal of ports 128 b, and a secondexpandable drape 140 b operatively connected to and at leastsubstantially surrounding stem 128 b at a location proximal of ports 128b. Drapes 140 a, 140 b have an un-deployed orientation, as seen in FIG.13, in which the respective outer radial edge 141 a, 141 b of drapes 140a, 140 b are in close proximity to and/or in contact with the outersurface of stem 128, and a deployed orientation, as seen in FIG. 14, inwhich outer radial edges 141 a, 141 b of drapes 140 a, 140 b are spaceda radial distance from the outer surface of stem 128.

It is envisioned and within the scope of the present disclosure, thatdrapes 140 a, 140 b may be maintained in the un-deployed orientation bya tear-away or break-away sleeve or liner (not shown) which surroundsdrapes 140 a, 140 b. Accordingly, drapes 140 a, 140 b may be deployed bytearing away the sleeve or liner. It is further contemplated that eachdrape 140 a, 140 b may be fabricated from a flexible material, whereinthe inner radial edge thereof is secured to the outer surface of stem128 and the outer radial edge thereof may include a shape memory alloyhoop or ring operatively connected therewith. In this manner, the ringmay have a collapsed or biased condition in which the ring is in closeproximity to the outer surface of stem 128, to maintain the flexiblematerial in an un-expanded condition, and an expanded or un-biasedcondition in which the ring extends a radially distance from the outersurface of stem 128, to stretch the flexible material radially outwardto an expanded condition.

As seen in FIG. 15, when used in connection with surgical staplingapparatus 10, drapes 140 a, 140 b function to maintain and hold theproximal and distal inverted flaps of the tissue “T” away from eachother thereby providing a clear line of site from ports 128 b formed instem 128 and the staple line “S” of anastomosis site “A”.

With continued reference to FIG. 15, use of the wound treatment materialdispersion system of FIGS. 13 and 14, in connection with surgicalstapling apparatus 10, is shown and described. In operation, the distaltissue “T” is sutured to stem 128 of anvil member 126 by a purse-stringsuture “P” at a location wherein the purse-string suture “P” ispositioned distally of first drape 140 a and, in particular, distally ofouter radial edge 141 a thereof. The proximal tissue “T” is sutured tostem 128 of anvil member 126 or connection means 30 by a purse-stringsuture “P”, preferably at a location proximal of outer radial edge 141 bof drape 140 b.

With tissues “T” sutured to stem 128 and/or connection means 30, drapes140 a, 140 b are deployed, as described above, in order for outer radialedge 141 a, 141 b to radially expand. Anvil member 126 is thenapproximated toward staple pusher member 22 so as to approximate distaland proximal tissue “T”. Once again, as described above, drapes 140 a,140 b hold the distal and proximal tissues “T”, in the vicinity ofpurse-string sutures “P”, separate from one another thereby providing aclear line of site between ports 128 b of stem 128 and staple line “S”.

Once the proper or desired distance is set between anvil member 126 andstaple pusher member 22, interlock means 32 (see FIG. 1) may be releasedand actuating handles 14 may be pivoted to fire surgical staplingapparatus 10 and drive the staples through the tissue against anvilmember 126 to complete the circular anastomosis of tissues “T”. Eitherprior to, during or after the firing of surgical stapling apparatus 10,wound treatment material “W” is dispensed from anvil member 126, in anyof the methods described herein above or herein below, to coat thestaple line “S” to thereby reduce the occurrences of leaking and/orbleeding.

In particular, wound treatment material “W” is ejected from ports 128 bof stem 128. For example, the wound treatment material “W” may beretained in an ampoule (not shown), which is ruptured to release thewound treatment material “W” contained therein, in a manner similar tothat disclosed above with regard to FIGS. 4-8. It is further envisioned,for example, that a fluid conduit (not shown) may be provided which maydeliver the wound treatment material “W” to ports 128 b to be dispensedtherefrom.

Drapes 140 a, 140 b allow for wound treatment material “W” to bedispensed from stem 128 of anvil member 126 to a target location (e.g.,the staple line “E”) and substantially prevent the application orspreading of wound treatment material “W” to unintended sections of bodytissue.

As seen in FIG. 16, stem 128 of anvil member 126 may include a firstannular groove 144 a formed distally of ports 128 b and a second annulargroove 144 b formed proximally of ports 128 b. In this manner, in use,the distal tissue “T” to be anastomosed is purse-string sutured to stem128 such that the distal tissue “T” is positioned within first annulargroove 144 a. Additionally, the proximal tissue “T” to be anastomosed ispurse-string sutured to stem 128 such that the proximal tissue “T” ispositioned within second annular groove 144 b.

In this manner, when anvil member 126 is approximated toward staplepusher member 22 and the distal and proximal tissues “T” are pinchedtherebetween along the staple line, grooves 144 a, 144 b maintain aportion of the distal and proximal tissue “T” (i.e., the portion of thetissue “T” between the staple line and grooves 144 a, 144 b) separatefrom one another thus maintaining a clear line of site between ports 128b and the staple line. In this manner, as wound treatment material “W”is dispensed from ports 128 b of stem 128, the wound treatment material“W” may enter and contact the tissues “T” along the staple line.

Turning now to FIG. 17, in an alternate embodiment, if the woundtreatment material “W” is to be applied to the tissues “T” along thestaple line, following firing and before opening surgical stapler 10, itis envisioned and contemplated that the annular knife 50 of surgicalstapling apparatus 10 be provided with a plurality of opening orapertures 52 formed therein. Preferably, when annular knife 50 is in anadvanced position, apertures 52 will substantially radially align withports 128 b of stem 128 and with the staple line of the anastomosis.Accordingly, following firing of surgical stapling apparatus 10, thewound treatment material “W” may be dispensed from ports 128 b of stem128 and pass through apertures 52 of annular knife 50 in order tocontact and coat the staple line.

Turning now to FIGS. 18-21, a wound treatment dispersion system,according to a further embodiment of the present disclosure, is shownand described. The dispersion system of FIGS. 18-21 includes an anvilmember 226 which is connectable to connection means 30 of surgicalstapling apparatus 10.

As seen in FIGS. 18 and 19, anvil member 226 includes a hollow tubularstem 228 having an open proximal end 228 a, and an anvil head 230operatively connected to a distal end of stem 228. Stem 228 includes atleast one, and in certain embodiments, a plurality of longitudinallyoriented slots or elongate windows 229 formed therein, around thecircumference of stem 228. Anvil member 226 further includes a flexibletubular member 231 operatively disposed within and deployable from eachwindow 229: Stem 228 defines a lumen 233 therethrough which is in fluidcommunication with each tubular member 231 (see FIGS. 20 and 21).

As seen in FIG. 18, anvil member 226 has a first condition wherein eachtubular member 231 is in an undeployed condition wherein each tubularmember 231 is disposed within a respective window 229. As seen in FIG.19, anvil member 226 has a second condition wherein each tubular member231 is in a deployed condition wherein each tubular member 231 is bentalong an elbow, flex point or region of weakness 231 a in such a mannerthat each tubular member 231 extends radially outward from windows 229.

Each tubular member 231 is capable of retaining, carrying and/ortransmitting wound treatment material “W” therein or therethrough. Aswill be described in greater detail below, in use, as anvil member 226is moved from the first condition to the second condition, tubularmembers 231 are deployed. The deployment of tubular members 231 causestubular members 231 to develop an opening, fissure or crack along flexpoint 231 a. In this manner, wound treatment material “W” may bedispensed therefrom.

Flex point 231 a is formed along tubular members 231 at a location suchthat when anvil member 226 is in the second condition and tubularmembers 231 are deployed, flex points 231 a are located in closeproximity to or in axial and radial alignment with anastomosis site “A”.In this manner, when wound treatment material “W” is dispersed fromtubular members 231, the wound treatment material “W” is dispersed intoand/or onto anastomosis site “A”.

Turning now to FIGS. 20 and 21, use of the wound treatment materialdispersion system of FIGS. 18 and 19, in connection with surgicalstapling apparatus 10, is shown and described. In operation, anvilmember 226 is introduced into one side of the anastomosis according toany known technique. The tissue “T” is then purse string sutured to stem228 such that purse string suture “P” is located distally of windows229. Stem 228 of anvil member 226 may then be operatively connected toconnection means 30 such that lumen 30 a of connection means 30 is influid communication with lumen 233 of stem 228 of anvil member 226. Withanvil member 226 connected to the distal end of surgical staplingapparatus 10, the surgical procedure is continued as described above.

Anvil member 226 is then approximated toward staple pusher member 22 byrotating grip member 18 (see FIG. 1). As grip member 18 is rotated,anvil member 226 is drawn into position adjacent staple pusher member 22to locate the ends of tissue “T” therebetween. Simultaneously therewith,as anvil member 226 is drawn towards staple pusher member 22, tubularmember 231 of the wound treatment material dispersion system aredeployed such that flex points 231 a are located in close proximity toor in axial and radial alignment with anastomosis site “A”.

As tubular members 231 are deployed, tubular members 231 will develop acrack or fissure (not shown) along flex points 231 a. In this manner,wound treatment material “W” may be dispensed onto anastomosis site “A”.Anvil member 226 is constructed in such a manner that when tubularmembers 231 are in the deployed condition, flex points 231 a do notextend radially beyond annular knife blade 50.

Once the wound treatment material “W” has been dispensed onto tissue “T”and once tissue “T” has been clamped between anvil member 226 and staplepusher member 22, interlock means 32 (see FIG. 1) may be released andactuating handles 14 may be pivoted to drive the staples through tissue“T” and against head 230 of anvil member 226 to complete the circularanastomosis of the tubular organ.

Turning now to FIGS. 22-24, a surgical stapling apparatus in accordancewith an alternate embodiment of the present disclosure is showngenerally as 300. Surgical stapling apparatus 300 is substantiallysimilar to surgical stapling apparatus 10 and thus will only bediscussed in detail to the extent necessary to identify differences inconstruction and operation.

As seen in FIGS. 22-24, surgical stapling apparatus 300 includes a woundtreatment material dispersion system configured and adapted to dispensewound treatment material “W” to a target surgical site. The woundtreatment material dispersion system of FIGS. 22-24 includes at leastone annular array, in certain embodiments, two annular arrays, ofdeployable needles 350 positioned within needle receiving slots 352formed in a distal end of staple pusher member 322. Each needle 350 isbiased to a retracted position within its respective needle receivingslot 352 by a biasing member or spring 354 positioned about each needle350 and disposed between an inner distal surface 322 a of staple pushermember 322 and a flange 350 a formed at a proximal end of each needle350.

A quantity of wound treatment material “W” is provided within eachneedle receiving slot 352, at a location proximal of needle 350. Aplurality of rigid, semi-rigid or flexible containers, here shown assemi-rigid or flexible capsules 356, containing wound treatment material“W” may be provided, one each, within needle receiving slots 352. Eachcapsule 356 encloses, encapsulates and/or includes a quantity of woundtreatment material therein.

In operation, as seen in FIGS. 22 and 24, with tissue “T” clampedbetween anvil member 330 and staple pusher member 322, actuation ofhandle members 14 (see FIG. 1), results in distal advancement of fingers358 through needle receiving slots 352. Fingers 358 push capsules 356(containing wound treatment material “W” therein) in a distal directionagainst a proximal end of needles 350 resulting in the deployment ofneedles 350 out of needle receiving slots 352. Simultaneously therewithor immediately thereafter, needles 350 are deployed (e.g., distallyadvanced) to penetrate at least one layer of tissue “T”.

Once needles 350 are fully deployed, further actuation of handle members14 results in fingers 358 exerting a compressive force on capsules 356to cause capsules 356 to rupture and dispense wound treatment material“W” into respective needle receiving slot 352. With capsules 356ruptured, continued actuation of handle members 14 and distaladvancement of fingers 358 results in the expulsion or dispensing ofwound treatment material “W” out through and/or about needles 350.

Following firing of surgical stapling apparatus 300, handle members 14are released to move fingers 358 in a proximal direction thus allowingneedles 350 to retract into slots 352 as a result of the biasing forcecreated by springs 354.

In this manner, the annular array of staples 324 provide the necessaryretraining force to mechanically hold the adjacent layers of tissue “T”secured to one another during the healing process while a suitable woundtreatment material “W” fills the gaps between adjacent staples 324 in aparticular annular array of staples 324.

It is contemplated and within the scope of the present disclosure toprovide a surgical stapling apparatus containing no staples whatsoever.As such, the anastomosis and the joining of tissue “T” would beaccomplished by the adherence of tissues “T” to one another by woundtreatment material “W”.

It is further envisioned and contemplated that surgical staplingapparatus 300 may be configured to drive needles 350 through both layersof tissue “T”. As such, surgical stapling apparatus 300 may also beconfigured to dispense wound treatment material “W” through needles 350as needles 350 are being retracted into staple pusher member 322. Inthis manner, wound treatment material “W” may span across both layers oftissue “T” on either side of the anastomosis.

Turning now to FIGS. 25-28, a splash guard 400 is shown and will bedescribed. Splash guard 400 may be used with any of the surgicalapparatus' disclosed above. Splash guard 400 is intended to preventleakage of wound treatment material from the outer surface of theanastomosis. As will be described in greater detail below, in use,splash guard 400 creates a barrier around the periphery of theanastomosis which inhibits and/or prevents leakage of wound treatmentmaterial “W” to other parts of the anatomy by localizing the woundtreatment material “W” to the site of the anastomosis. Additionally,splash guard 400 may help to reduce to occurrence of bleeding at or fromthe site of the anastomosis.

As seen in FIGS. 25-27, splash guard 400 includes a central hub 402including a central lumen 404 and defining a central longitudinal axis“X”. Splash guard 400 further includes at least one spoke 406 extendingradially outward from central hub 402. As seen in FIG. 25, splash guard400 may include four spokes 406 extending from central hub 402 whereinspokes 406 are equally spaced from one another. However, it isenvisioned and within the scope of the present disclosure, that anynumber of spokes may be provided and which spokes may be spaced anydistance from one another. It is further envisioned that spokes 406 maybe replaced by an annular disc (not shown) extending radially and/ororthogonally from central hub 402.

Splash guard 400 further includes an annular flange 408 interconnectingthe outer or distal ends of spokes 406. Annular flange 408 providessupport for spokes 406, as well as, and as will be described in greaterdetail below, a surface through which the staples of the surgicalstapling apparatus are fired.

Splash guard 400 further includes an annular cuff 410 integrallyconnected to an outer terminal edge of annular flange 408. Cuff 410includes an upper lip 412 extending distally from a first or distalsurface of annular flange 408 and a lower lip 414 extending proximallyfrom a second or proximal surface of annular flange 408. Preferably,upper lip 412 terminates in an upper annular rim 412 a having a centraldiameter which is less than an outer diameter of annular flange 408.Likewise, lower lip 414 preferably terminates in a lower annular rim 414a having a central diameter which is less than an outer diameter ofannular flange 408. In this manner, as seen in FIG. 26, cuff 410 has aC-shaped or concave cross-sectional profile.

Preferably, at least a portion of splash guard 400 and, more preferably,the entirety of splash guard 400 is fabricated from a semi-rigid,bio-absorbable material. In this manner, those portions of splash guard400 left at the anastomosis site, following the surgical staplingprocedure, will help to prevent the occurrences of stricture at or nearthe site of the anastomosis.

Turning now to FIG. 28, an exemplary method of using splash guard 400,in combination with any one of the surgical stapling apparatus'described above, will now be shown and described. According to onemethod of operation, the ends of the organ to be joined (e.g., thetissue “T”) are secured over staple pusher member 22 and anvil member 26by a purse string suture “P” prior to approximation of anvil member 26in relation to staple pusher member 22.

With tissue “T” sutured to staple pusher member 22 and anvil member 26,splash guard 400 is positioned on stem 128 of anvil member 26 such thatstem 128 extends through lumen 404 of central hub 402. Preferably,splash guard 400 is dimensioned so that upper and lower lips 412, 414 ofcuff 410 are disposed radially outward of radially outer-most annularstaple line of staple pusher member 22. Additionally, splash guard 400is dimensioned so that an inner annular terminal edge 408 a (see FIGS.25 and 26) of annular flange 408 is disposed radially inward of theannular knife cut line.

With splash guard 400 positioned on stem 128 of anvil member 26, stem128 of anvil member is operatively connected to the connection means(not shown) of staple pusher member 22. Anvil member 26 is thenapproximated towards staple pusher member 22 in the manner describedabove. Prior to, during or after approximation of anvil member 26 towardstaple pusher member 26, it is envisioned that wound treatment material“W” may be sprayed or dispensed onto tissue “T” as described above(e.g., from ports formed in the stem of anvil member 26). Desirably,sufficient wound treatment material “W” is sprayed onto tissue “T” tosufficiently cover that portion of tissue “T” to be anastomosed. It isenvisioned that central hub 402 may include at least one aperture (notshown) formed therein to enable wound treatment material “W” to bedispensed through and radially outward from central hub 402.

Desirably, splash guard 400 is dimensioned so that rims 412 a, 414 a ofupper and lower lips 412, 414 of cuff 410 are in contact with an outersurface of tissue “T”. As such, cuff 410 will act as a barrier to helplocalize any fluid (i.e., wound treatment material “W”, blood, etc.) atthe outside of the anastomosis site.

As anvil member 26 is approximated towards and clamped against staplepusher member 22, wound treatment material “W” will tend to be squeezedradially inward and radially outward of the anastomosis site. Asdiscussed above, cuff 410 of splash guard 400 acts as a barrier toprevent wound treatment material “W” from spreading through theoperative site.

With wound treatment material “W” dispersed over tissue “T” and withsplash guard 400 positioned on stem 128 of anvil member 26, stem 128 ofanvil member 26 is operatively connected to connection means 30 locatedwithin staple pusher member 22. With anvil member 126 connected to thedistal end of surgical stapling apparatus 10, the surgical procedure iscontinued as described above. In particular, the surgical staplingapparatus may be fired by releasing interlock means 32 (see FIG. 1) andactuating handles 14 may be pivoted to drive the staples through tissue“T”, through annular flange 408, and against anvil member 26 to completethe circular anastomosis of tissue “T”. Additionally, as the surgicalstapling apparatus is being fired, the annular knife is driven throughtissue “T” and annular flange 408 of splash guard 400 to thereby severthat portion of tissue “T” and that portion of annular flange 408disposed radially inward of the annular knife blade. In so doing,central hub 402 and spokes 406 are separated from the remainder ofsplash guard 400. Accordingly, as seen in FIG. 27, the annular knifeblade creates a knife cut line 408 b in annular flange 408.

Turning now to FIGS. 29-33, a wound treatment material dispersionsystem, according to another embodiment of the present disclosure isshown generally as 500. As seen in FIGS. 29-31, wound treatment materialdispersion system 500 includes a ring or disc 502 defining an innerterminal edge 502 a and an outer terminal edge 502 b. Dispersion system500 further includes at least one of an annular inner wall 504integrally connected to inner terminal edge 502 a of disc 502 and anannular outer wall 506 integrally connected to outer terminal edge 502 bof disc 502. Preferably, as seen in FIGS. 30 and 31, dispersion system500 includes both an annular inner wall 504 and an annular outer wall506.

Desirably, annular inner wall 504 and annular outer wall 506 aresubstantially orthogonal with respect to disc 502. In one embodiment, asseen in FIG. 30, disc 502 is positioned between an upper terminal edge504 a, 506 a of inner and outer walls 504, 506, respectively, and alower terminal edge 504 b, 506 b of inner and outer walls 504, 506,respectively. In this manner, dispersion system 500 defines a first orupper annular channel 508 a and a second or lower annular channel 508 b.Desirably, wound treatment material “W” is disposed or deposited withinat least one of first and second annular channels 508 a, 508 b.

Additionally, as seen in FIG. 30, annular outer wall 506 preferably hasa height which is greater than a height of annular inner wall 504.Alternatively, it is envisioned that the height of annular outer wall506 may be substantially equal to or less than the height of annularinner wall 504.

As seen in FIG. 31, in another embodiment, disc 502 may be positionedeither at upper terminal edges 504 a, 506 a of inner and outer walls504, 506, respectively, or at lower terminal edges 504 b, 506 b of innerand outer walls 504, 506, respectively. In this manner, a single annularchannel 508 is defined for retaining a quantity of wound treatmentmaterial “W” therein.

As seen in FIGS. 29-31, disc 502 is preferably provided with a series ofopening or apertures 510 formed therein and preferably therearound. Inthis manner, wound treatment material “W” is free to and/or capable offlowing to a side of disc 502 opposite the side on which wound treatmentmaterial “W” is deposited.

Preferably, at least a portion of dispersion system 500 and, morepreferably, the entirety of dispersion system 500, is fabricated from asemi-rigid, bio-absorbable material. In this manner, those portions ofdispersion system 500 left at the anastomosis site, following thesurgical stapling procedure, will help to prevent the occurrences ofstricture at or near the site of the anastomosis.

As seen in FIGS. 29-31, annular inner wall 504 of dispersion system 500defines a central aperture 510. Preferably, as will be shown in FIGS. 32and 33, dispersion system 500 is dimensioned such that when dispersionsystem 500 is positioned on stem 28 of anvil member 26, annular outerwall 506 is positioned radially outward of an outer radial terminal edgeof anvil member 26 and inner terminal edge 502 a of disc 502 terminatesradially inward of a radially inner-most staple line (not shown).

Turning now to FIGS. 32 and 33, exemplary methods of using dispersionsystem 500, in connection with a surgical stapling apparatus 10, will beshown and described. As seen in FIG. 32, with tissue “T” purse stringsutured to stem 28 of anvil member 26, dispersion system 500, includinga quantity of wound treatment material “W” disposed within one ofannular channels 508 a, 508 b, is placed over stem 28 and brought intocontact with tissue “T” in a manner so as bring wound treatment material“W” into contact with tissue “T”. In so doing, wound treatment material“W” is transferred to tissue “T”. With wound treatment material “W”transferred to tissue “T”, dispersion system 500 may be removed and thesurgical stapling process continued as described above.

Alternatively, as seen in FIG. 33, dispersion system 500 may be left inplace against tissue “T” following the anastomosis procedure. Inparticular, with dispersion system 500 positioned on stem 28 of anvilmember 26, stem 28 of anvil member 26 coupled to connection means 30 andanvil member 26 is approximated toward staple pusher member 22. In sodoing, wound treatment material “W” is squeezed through or will spreadthrough openings 510 to cover both layers of tissue “T” to beapproximated. With dispersion system 500 so disposed, the surgicalstapling process is continued as describe above in order to complete theanastomosis. According to the present procedure, dispersion system 500will remain in position between the two adjacent layers of anastomosedtissue “T”.

It is envisioned and within the scope of the present disclosure thatwould treatment material “W” may be a fluid, a solid or some combinationof a fluid and a solid (e.g., foam). For example, wound treatmentmaterial “W” may be an expandable foamy fluid which may be injected,sprayed and/or otherwise dispersed or applied between two layers oftissue “T”. The foam wound treatment material “W” may be an adhesivecapable of holding the two layers of tissue “T” together until such timeas normal tissue healing may occur.

The adhesive may be moisture activated, two-part reactive, or any othersuitable biocompatible type adhesive. If a two-part reactive adhesive isused, the adhesive may be mixed or cured in a number of differentmanners. For example, the adhesive may be mixed or cured by 1) providinga first and/or a second part of the adhesive in micro-spheres whichrupture upon application of pressure, vibration, shock or other suitablemeans; 2) the first part of adhesive being a foam and the other part ofthe adhesive being encapsulated in micro-spheres or the like; and 3) thefirst part of the adhesive is a foaming agent encapsulated inmicro-spheres and which may be combined with a singe part adhesive, orwith one or both parts of a two-part adhesive.

In use, as the bubble in the foam based adhesive collapses, directcontact between the surfaces of tissue “T” will occur and create anopportunity to tissue cells to grow and thereby bring about naturalhealing. Using an adhesive that is foam based helps to maintain theadhesive in the location in which it is applied and helps to maintainthe adhesive in contact with tissue “T” until curing of the adhesive maycommence.

Turning now to FIGS. 34 and 35, an alternative method of dispensingwound treatment material “W” to anastomosis site “A” is shown anddescribed. According to the method disclosed in FIGS. 34 and 35, theends of the organ to be joined (e.g., the tissue “T”) are secured overstaple pusher member 22 and anvil member 26 by a purse string suture “P”prior to approximation of anvil member 26 in relation to staple pushermember 22.

With tissue “T” sutured to staple pusher member 22 and anvil member 26,stem 128 of anvil member 26, stem 128 of anvil member 26 is operativelyconnected to the connection means (not shown) of staple pusher member22. Prior to approximation of anvil member 26 and staple pusher member22, a tip, nozzle or distal end of a fluid dispensing or delivery device“D” (e.g., a syringe, a blunt hypodermic needle, etc.) is placed betweenthe layers of tissue “T” to be anastomosed.

With the distal tip of dispensing device “D” so positioned, anvil member26 is slowly approximated towards staple pusher member 22 in the mannerdescribed above, thereby trapping the distal end of dispensing device“D” therebetween. As dispensing device “D” is withdrawn from theoperative site and the distal tip thereof withdrawn from between thelayers of tissue “T”, wound treatment material “W” is dispensed and/orotherwise injected therebetween.

It is envisioned and within the scope of the present disclosure that oneor more rows of staples “S” may be fired radially inward of, radiallyoutward of, or on both sides of the distal tip of dispensing device “D”,either before, during or after the wound treatment material “W” isdispensed between the layers of tissue “T”. Desirably, sufficient woundtreatment material “W” is dispensed between the layers of tissue “T” tosufficiently cover that portion of tissue “T” to be anastomosed.

After a period of time, direct contact between the layers of tissue “T”will create an opportunity for tissue cells to grow therebetween,bringing about natural healing. Simultaneously therewith, the stapleswill begin to dissolve and be absorbed into the body as the naturalhealing process supplies greater strength and security to theanastomosis site.

While it is typical for the surgical staples to be applied in anorientation which is tangential to the annular staple line, it isenvisioned and within the scope of the present disclosure for thesurgical staples to be applied in an orientation which is orthogonal toor perpendicular to the annular staple line. In this manner, the stapleswould be better able to straddle the distal tip of dispensing device “D”and thereby better maintain the distal tip thereof in a straight lineduring withdrawal of the distal tip from between the layers of tissue“T”.

It is further envisioned that the surgical staples may be closed and/orformed into a D-shape instead of a B-shape. In this manner, the surgicalstaple, when fired from staple pusher member 22 and formed against anvilmember 26, would be able to straddle the distal tip of dispensing device“D” and thereby better maintain the distal tip in a straight line duringwithdrawal of the distal tip from between the layers of tissue “T”.

It is envisioned and within the scope of the present disclosure, thatthe process of placing a tip of a needle between a pair of layers oftissue which are to joined to one another and then withdrawing the tipof the needle while simultaneously dispensing wound treatment materialbetween the layers of tissue, following the approximation of the layersof tissue to one another, may be used in conjunction with annular and/orlinear type surgical stapling apparatus or instruments.

It is contemplated that the wound treatment material “W” is any materialfor joining, healing, sealing or otherwise treating tissue. In apreferred embodiment, the wound treatment material is a bio-compatiblesealant, including, and not limited, to sealants which cure upon tissuecontact, sealants which cure upon exposure to ultraviolet (UV) light,sealants which are two-part systems which are kept isolated from oneanother and are combined or any combinations thereof. Any known suitableadhesive may be used. In one embodiment, it is contemplated that suchsealants and/or adhesives are curable. For example, sealants may have acure time of from about 10 to 15 seconds may be used. In preferredembodiments, the sealant and/or adhesive is a bioabsorbable and/orbio-resorbable material. In another embodiment, it is contemplated thata sealant and/or adhesive having a cure time of about 30 seconds may beused. It is further envisioned that wound treatment material “W” may bea pre-cured adhesive or sealant. The pre-cured adhesive or sealant mayreact with the moisture and/or heat of the body tissue to therebyactivate the sealing and/or adhesive properties of the sealant oradhesive.

In certain preferred embodiments, the wound treatment material comprisesa sealant. Such a sealant is desirably a PEG-based material. Examples ofclasses of materials useful as the sealant and/or adhesive includeacrylate or methacrylate functional hydrogels in the presence of abiocompatible photoinitiator, alkyl-cyanoacrylates, isocyanatefunctional macromers with or without amine functional macromers,succinimidyl ester functional macromers with amine or sulfhydrylfunctional macromers, epoxy functional macromers with amine functionalmacromers, mixtures of proteins or polypeptides in the presence ofaldehyde crosslinkers, Genipin, or water-soluble carbodiimides, anionicpolysaccharides in the presence of polyvalent cations, etc.

Some specific materials which may be utilized include isocyanateterminated hydrophilic urethane prepolymers derived from organicpolyisocyanates and oxyethylene-based diols or polyols, including thosedisclosed in U.S. Pat. Nos. 6,702,731 and 6,296,607 and U.S. PublishedPatent Application No. 2004/0068078; alpha-cyanoacrylate based adhesivesincluding those disclosed in U.S. Pat. No. 6,565,840; alkyl ester basedcyanoacrylate adhesives including those disclosed in U.S. Pat. No.6,620,846; adhesives based on biocompatible cross-linked polymers formedfrom water soluble precursors having electrophilic and nucleophilicgroups capable of reacting and cross-linking in situ, including thosedisclosed in U.S. Pat. No. 6,566,406; two part adhesive systemsincluding those based upon polyalkylene oxide backbones substituted withone or more isocyanate groups in combination with bioabsorbable diaminecompounds, or polyalkylene oxide backbones substituted with one or moreamine groups in combination with bioabsorbable diisoycanate compounds asdisclosed in U.S. Published Patent Application No. 2003/0032734, thecontents of which are incorporated by reference herein; and isocyanateterminated hydrophilic urethane prepolymers derived from aromaticdiisocyanates and polyols as disclosed in U.S. Published PatentApplication No. 2004/0115229, the contents of which are incorporated byreference herein.

It is envisioned and within the scope of the present disclosure thatwound treatment material “W” may include one or a combination ofadhesives, hemostats, sealants, or any other tissue or wound-treatingmaterial. Surgical biocompatible wound treatment materials “W”, whichmay be used in accordance with the present disclosure, include adhesiveswhose function is to attach or hold organs, tissues or structures,sealants to prevent fluid leakage, and hemostats to halt or preventbleeding. Examples of adhesives which can be employed include proteinderived, aldehyde-based adhesive materials, for example, thecommercially available albumin/glutaraldehyde materials sold under thetrade designation BioGlue™ by Cryolife, Inc., and cyanoacrylate-basedmaterials sold under the trade designations Indermil™ and Derma Bond™ byTyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively.Examples of sealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc. Examples of hemostatmaterials, which can be employed, include fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats. Examples of commercially available hemostat materials arefibrinogen-thrombin combination materials sold under the tradedesignations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™ soldby Baxter International, Inc. Hemostats herein include astringents,e.g., aluminum sulfate, and coagulants.

The medicament may include one or more medically and/or surgicallyuseful substances such as drugs, enzymes, growth factors, peptides,proteins, dyes, diagnostic agents or hemostasis agents, monoclonalantibodies, or any other pharmaceutical used in the prevention ofstenosis.

Wound treatment material “W” may include visco-elastic film formingmaterials, cross-linking reactive agents, and energy curable adhesives.It is envisioned that wound treatment material “W”, and in particular,adhesive may be cured with the application of water and/or glycerinthereto. In this manner, the water and/or glycerin cure the adhesive andhydrate the wound.

It is further contemplated that wound treatment material “W” mayinclude, for example, compositions and/or compounds which accelerate orbeneficially modify the healing process when particles of thecomposition and/or compound are applied to or exposed to a surgicalrepair site. For example, the wound treatment material “W” may be atherapeutic agent which will be deposited at the repair site. Thetherapeutic agent can be chosen for its antimicrobial properties,capability for promoting repair or reconstruction and/or new tissuegrowth. Antimicrobial agents such as broad spectrum antibiotic(gentamycin sulfate, erythromycin or derivatized glycopeptides) whichare slowly released into the tissue can be applied in this manner to aidin combating clinical and sub-clinical infections in a tissue repairsite. To promote repair and/or tissue growth, wound treatment material“W” may include one or several growth promoting factors, e.g.,fibroblast growth factor, bone growth factor, epidermal growth factor,platelet derived growth factor, macrophage derived growth factor,alveolar derived growth factor, monocyte derived growth factor,magainin, and so forth. Some therapeutic indications are: glycerol withtissue or kidney plasminogen activator to cause thrombosis, superoxidedimutase to scavenge tissue damaging free radicals, tumor necrosisfactor for cancer therapy or colony stimulating factor and interferon,interleukin-2 or other lymphokine to enhance the immune system.

It will be understood that various modifications may be made to theembodiments of the presently disclosed surgical stapling apparatus andthe various dispensing systems and methods described above. Therefore,the above description should not be construed as limiting, but merely asexemplifications of preferred embodiments. Those skilled in the art willenvision other modifications within the scope and spirit of the presentdisclosure.

1. A surgical stapling apparatus, comprising: a body portion; anactuation assembly operatively supported at a proximal end of the bodyportion; a staple pusher member operatively disposed at a distal end ofthe body portion and being operatively connected to the actuationassembly for expelling staples from the body portion; an anvil assemblymovably mounted at the distal end of the body portion for movementtoward and away from the staple pusher member; an approximation assemblyextending between the body portion and the anvil assembly for moving theanvil assembly toward and away from the body portion; and a woundtreatment material dispersion system for delivering wound treatmentmaterial to a target surgical site, the dispersion system including: atleast one port formed in the anvil assembly oriented to dispense woundtreatment material in an outward direction; and an ampoule containing awound treatment material and being configured for selective dispositionwithin the anvil assembly and for selective fluid communication witheach of the at least one port.
 2. The surgical stapling apparatusaccording to claim 1, wherein the wound treatment material is at leastone of an adhesive, a sealant, a hemostat, and a medicament.
 3. Thesurgical stapling apparatus according to claim 1, wherein the anvilassembly comprises a hollow tubular stem including an open proximal end,the hollow tubular stem configured to receive the ampoule containing thewound treatment material.
 4. The surgical stapling apparatus of claim 3,wherein the anvil assembly further comprises a cap selectivelyoperatively connectable to the proximal end of the stem.
 5. The surgicalstapling apparatus of claim 1, wherein the ampoule is constructed from abreakable material, and wherein, during use, upon approximation of theanvil assembly and the body portion, the ampoule is compressed and woundtreatment material is delivered from the ampoule to the at least oneport of the anvil assembly.
 6. The surgical stapling apparatus accordingto claim 3, wherein the dispersion system includes a piston configuredand dimensioned for insertion into the hollow tubular stem of the anvilassembly to engage the ampoule upon approximation of the anvil assemblyand the body portion, the ampoule is compressed and wound treatmentmaterial is forced out through the port of the anvil assembly and onto atarget surgical site at least one of before, during and after firing ofthe surgical stapling apparatus.
 7. The surgical stapling apparatusaccording to claim 1, wherein the ampoule defines a lumen therethroughand includes a plunger slidably positioned within the lumen thereof. 8.The surgical stapling apparatus according to claim 7, wherein the lumenof the ampoule is in fluid communication with the port of the anvilassembly when the ampoule is positioned within the anvil assembly. 9.The surgical stapling apparatus according to claim 8, wherein thedispersion system includes a piston configured and dimensioned forinsertion into the lumen of the ampoule to engage the plunger and toforce the plunger through the lumen of the ampoule to dispense woundtreatment material contained in the ampoule out through the port of theanvil assembly and onto the target surgical site at least one of before,during and after firing of the surgical stapling apparatus.
 10. Thesurgical stapling apparatus according to claim 1, wherein the dispersionsystem further includes at least one drape supported on andsubstantially surrounding a stem of the anvil assembly, wherein thedrape includes an undeployed condition in which the drape is inrelatively close proximity to the stem of the anvil assembly, and adeployed condition in which the drape is in relatively spaced relationto the stem of the anvil assembly.
 11. The surgical stapling apparatusaccording to claim 10, wherein the dispersion system includes a firstdrape positioned distally of the port of the anvil assembly and a seconddrape positioned proximally of the port of the anvil assembly.
 12. Thesurgical stapling apparatus according to claim 11, wherein, when thedrapes are in the deployable condition, the drapes direct the dispersionof the wound treatment material.
 13. The surgical stapling apparatusaccording to claim 1, wherein a stem of the anvil assembly includes afirst annular groove formed distally of the port of the anvil assemblyand a second annular groove formed proximally of the port of the anvilassembly.
 14. The surgical stapling apparatus according to claim 1,further comprising an annular blade retractably disposed at a distal endof the body portion, wherein the annular blade includes a plurality ofopenings formed therein.
 15. The surgical stapling apparatus accordingto claim 1, further comprising a splash guard including a central hubdefining a lumen therethrough for receiving a stem of the anvil assemblyand an annular cuff supported on the central hub and extending at leastsubstantially therearound, wherein the annular cuff is disposed radiallyoutward of a staple line of the surgical stapling apparatus.
 16. Thesurgical stapling apparatus according to claim 15, wherein the splashguard further comprises at least one spoke interconnecting the annularcuff to the central hub.
 17. The surgical stapling apparatus accordingto claim 16, wherein the annular cuff of the splash guard is concave anddefines an upper rim and a lower rim, wherein the upper and lower rimsare dimensioned to contact an outer surface of the target surgical site.18. A kit for performing a surgical anastomotic procedure, the kitcomprising: a surgical stapling apparatus including: a body portion; anactuation assembly operatively supported at a proximal end of the bodyportion; a staple pusher member operatively disposed at a distal end ofthe body portion and being operatively connected to the actuationassembly for expelling staples from the body portion; an anvil assemblymovably mounted at the distal end of the body portion for movementtoward and away from the staple pusher member, the anvil assemblyincluding a stem defining a cavity and having an open proximal end, andat least one port formed in a surface of the stem; and an approximationassembly extending between the body portion and the anvil assembly formoving the anvil assembly toward and away from the body portion; atleast one ampoule containing a wound treatment material, the ampouleconfigured to be positioned within the cavity of the stem of the anvilassembly and for selective fluid communication with each of the at leastone port; and a splash guard including a central hub defining a lumentherethrough for receiving the stem of the anvil assembly and an annularcuff supported on the central hub and extending at least substantiallytherearound.
 19. The kit according to claim 18, further comprising a capoperatively connectable to the open proximal end of the stem of theanvil assembly.
 20. The kit according to claim 18, further comprising aplunger configured for selective slidable engagement with the openproximal end and the cavity of the stem of the anvil assembly.
 21. Ananvil assembly for use with a surgical stapling apparatus, the anvilassembly comprising: a stem defining a cavity and including an openproximal end and a distal end, the stem having at least one port formedthough the outer surface of the stem, wherein the at least one port isin fluid communication with the cavity of the stem; an anvil headoperatively connected to the distal end of the stem; and a woundtreatment material dispersion system including a wound treatmentmaterial configured for selective disposition within the cavity of thestem for selective fluid communication with the at least one port fordispensing the wound treatment material in an outward direction throughthe at least one port.
 22. The anvil assembly of claim 21, wherein thewound treatment material dispersion system includes an ampoulecontaining a quantity of wound treatment material, wherein the ampouleis configured for selective positioning within the cavity of the stem.23. The anvil assembly of claim 22, wherein the wound treatment materialdispersion system includes a cap selectively operatively connectable tothe proximal end of the stem to secure the ampoule within the cavity ofthe stem.
 24. The anvil assembly of claim 21, wherein the stem isoperatively connectable to a surgical stapling apparatus, the surgicalstapling apparatus including a body portion and a staple pusher memberoperatively disposed at a distal end of the body portion such that theanvil assembly is movably mounted at the distal end of the body portionfor movement toward and away from the staple pusher member, wherein uponapproximation of the anvil assembly and the body portion, the woundtreatment material is dispersed through the at least one port of thestem and onto a target surgical site.
 25. The anvil assembly of claim21, wherein the anvil stem includes at least one annular groove axiallyspaced from the at least one port.
 26. The anvil assembly of claim 25,wherein the anvil stem includes a first and a second axially spacedapart annular groove formed in the outer surface thereof and beingdisposed on opposed sides of the at least one port.